FDA to require stronger warnings on TNF blockers

ROCKVILLE, Md. Reports of cancer in children and adolescents have led the Food and Drug Administration to require its strongest warning label for a class of biotech drugs used to treat autoimmune disorders, the agency announced Tuesday.

The FDA is requiring a boxed warning to highlight the increased risk of cancer in children and adolescents taking TNF blockers. The drugs work by blocking tumor necrosis factor-alpha, a protein that can cause inflammation and damage to bones, cartilage and tissue when overproduced in the body, leading to diseases such as rheumatoid arthritis, Crohn’s disease and other disorders.

The class includes such drugs as Enbrel (etanercept) by Wyeth and Amgen, Abbott’s Humira (adalimumab), UCB’s Cimzia (certolizumab pegol) and Johnson & Johnson’s Simponi (golimumab).

In June 2008, the FDA launched an investigation into a link between TNF blockers and cancer in children and adolescents, and an analysis of reports of children treated with the drugs revealed an increased risk. About half of the cancers were lymphomas, and some cases were fatal.